Superior Hypogastric Blockade for Postoperative Pain

Pain, Postoperative Clinical Trial

Official title:

The Efficacy of Superior Hypogastric Blockade for Postoperative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428152
• Other study ID #: U1111-1205-2226
• Status: Completed
• Start date: February 9, 2018
• Est. completion date: July 24, 2018

Study information

• Verified date: February 2024
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary indication for superior hypogastric (SHP) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Percutaneous SHP blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. Because of the close proximity of SHP to major vessels, and structures like vertebral column (for posterior) and guts (for anterior) are being on the way of the needle, these percutaneous blocks are associated with serious complications. Performing SHP during hysterectomy surgery, gives advantages to rule out these complications by exploring the whole intraabdominal anatomy.

The investigators' theory is to find out if SHP blocks (during pelvic surgery) are useful for decreasing VAS pain scores and opioid consumption for postoperative pain.

Description:

Nerve blocks are frequently used in daily practice as an anesthetic and analgesia technique for surgery, postoperative pain and chronic pain. Total abdominal hysterectomy causes significant postoperative pain. Epidural blocks are frequently preferred for postoperative pain control, since most of the anesthetists are skilled with neuraxial blocks. However, an epidural catheter placement and epidural injections have some side effects and complications.

Pelvis is innervated by thoracolumbar and sacral segments. Autonomic (sympathetic and parasympathetic) and somatic (motor and sensory) nerves provide innervation of pelvis. The sympathetic nervous system, which transmits nociceptive messages from the viscera to brain, plays an important role in the transmission of visceral pain. Generally, in order to block transmission of nociceptive information from the pelvic viscera to the spinal cord, interruption of sympathetic pathways will be necessary. The sympathetic nerve block on the sympathetic nervous system for the management of chronic pelvic pain has been proposed at three main levels: ganglion impar, hypogastric plexus and L2 lumbar sympathetic blocks. By following the pelvic anatomy, there could be an alternative way for acute pain relief for abdominal hysterectomy: superior hypogastric block.

The superior hypogastric plexus lies retroperitoneally in front of L4 as a bunch of fibers. As these fibers descend, at the level of L5 they divide into the hypogastric nerves. The hypogastric nerves pass downward from L5-S1, following the concave curve of the sacrum and passing on each side of the rectum to form the inferior hypogastric plexus. These nerves continue their down¬ward course along each side of the bladder to provide innervation to the pelvic viscera and vasculature.

The primary indication for superior hypogastric block (SHNB) is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. Percutaneous SHP blocks can be done by using posterior approach (transdiscal) and paravertebral) and anterior techniques. All of these interventions should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. Because of the close proximity of SHP to major vessels, and structures like vertebral column (for posterior) and guts (for anterior) are being on the way of the needle, these percutaneous blocks are associated with complications.

SHP block has been performed by anesthetists or surgeons in Kocaeli Derince Training and Research Hospital regularly since they have discovered the advantages of this block technique. Performing SHP block during hysterectomy surgery, gives advantages to rule out these complications by exploring the whole intraabdominal anatomy. Based on the complexity of the pelvic innervation, SHP blocks do not offer a total painless period like central neuraxial blocks for sure. If SHP block is performed in patients who do not have epidural catheters, it can be useful to decrease postoperative pain scores and opioid or NSAID consumption significantly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 24, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA I - II

• Elective hysterectomy

Exclusion Criteria:

• ASA III

• Different kind of surgery

• Known allergy to local anesthetic drugs

• Different analgesia protocol (ie: epidural, TAP block,..)

• Refusal of the patient

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disease
• Hysterectomy
• Pain, Postoperative
• Superior Hypogastric Plexus Block

Intervention

Procedure:
• superior hypogastric block
superior hypogastric blockade during surgery

Locations

Country	Name	City	State
Turkey	Derince Training and Research Hospital	Kocaeli	Derince

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Choi JW, Kim WH, Lee CJ, Sim WS, Park S, Chae HB. The Optimal Approach for a Superior Hypogastric Plexus Block. Pain Pract. 2018 Mar;18(3):314-321. doi: 10.1111/papr.12603. Epub 2017 Jul 6. — View Citation

de Leon-Casasola OA, Kent E, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Pain. 1993 Aug;54(2):145-151. doi: 10.1016/0304-3959(93)90202-Z. — View Citation

Erdine S, Yucel A, Celik M, Talu GK. Transdiscal approach for hypogastric plexus block. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):304-8. doi: 10.1016/s1098-7339(03)00191-3. — View Citation

Plancarte R, de Leon-Casasola OA, El-Helaly M, Allende S, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Reg Anesth. 1997 Nov-Dec;22(6):562-8. — View Citation

Rapp H, Ledin Eriksson S, Smith P. Superior hypogastric plexus block as a new method of pain relief after abdominal hysterectomy: double-blind, randomised clinical trial of efficacy. BJOG. 2017 Jan;124(2):270-276. doi: 10.1111/1471-0528.14119. Epub 2016 J — View Citation

Sindt JE, Brogan SE. Interventional Treatments of Cancer Pain. Anesthesiol Clin. 2016 Jun;34(2):317-39. doi: 10.1016/j.anclin.2016.01.004. — View Citation

Turker G, Basagan-Mogol E, Gurbet A, Ozturk C, Uckunkaya N, Sahin S. A new technique for superior hypogastric plexus block: the posteromedian transdiscal approach. Tohoku J Exp Med. 2005 Jul;206(3):277-81. doi: 10.1620/tjem.206.277. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain Scores	Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever) (PACU: Post-anesthesia care unit) VAS-PACU: VAS scores at PACU VAS 1: VAS scores at postoperative 1st hour (ward) VAS 6: VAS scores at postoperative 6th hour (ward) VAS 12: VAS scores at postoperative 12th hour (ward) VAS 24: VAS scores at postoperative 24th hour (ward) VAS 48: VAS scores at postoperative 48th hour (ward)	postoperative 48 hour follow-up (PACU and ward)
Primary	Postoperative Analgesic Consumption	Total number of non-steroid anti-inflammatory drug (NSAID) and opioid vials that are applied to patients in post-anesthesia care unit (PACU) and at ward will be recorded.; Target VAS score for NSAID is >4; if there is no response to NSAID and pain is worsening opioid drugs will be applied (this is our routine clinical practice) NSAID: Diclofenac sodium 75mg per vial; opioid: Tramadol 100mg per vial.	postoperative 48 hour follow-up (PACU and ward)
Secondary	Rescue Analgesic Time	Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)	48 hours (time to the first analgesic demand will be recorded)
Secondary	Duration of Operation	the time from the the first incision to the skin to skin closure.	from the induction of anesthesia and the end of the surgery
Secondary	Length of Hospital Stay	length of hospital stay time will be recorded	assessed up to 1 week
Secondary	Number of Participants With Complications Due to SHP Block	intra/postoperative complications will be noted. (post-operative nausea and vomiting (PONV) or others: ie: intra-vascular local anesthetic injection, vascular puncture, hemodynamical changes after injection,.. )	From the SHP block time (intraoperative) until discharge